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  5. NDC Package Code: 50488-4125-1 Diphenhydramine Hcl 12.5mg Antihistamine

NDC Package 50488-4125-1 Diphenhydramine Hcl 12.5mg Antihistamine

Diphenhydramine Hydrochloride Bar, Chewable Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50488-4125-1
Package Description:
20 BAR, CHEWABLE in 1 BOTTLE
Product Code:
50488-4125
Proprietary Name:
Diphenhydramine Hcl 12.5mg Antihistamine
Non-Proprietary Name:
Diphenhydramine Hydrochloride
Substance Name:
Diphenhydramine Hydrochloride
Usage Information:
Adults and children 12 years and over:Take 2 to 4 soft chews (25 mg to 50 mg) every 4 to 6 hours, or as directed by a doctorDo not take more than 6 times in 24 hoursChew each soft chew thoroughly before swallowingChildren 6 to 11 years:Take 1 to 2 soft chews (12.5 mg to 25 mg) every 4 to 6 hours, or as directed by a doctor. Do not take more than 6 times in 24 hoursChew each soft chew thoroughly before swallowingChildren under 6 years: Do not use
11-Digit NDC Billing Format:
50488412501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
20 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1049900 - diphenhydrAMINE HCl 12.5 MG Chewable Tablet
  • RxCUI: 1049900 - diphenhydramine hydrochloride 12.5 MG Chewable Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Alexso, Inc
    Dosage Form:
    Bar, Chewable - A solid dosage form usually in the form of a rectangle that is meant to be chewed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    02-08-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50488-4125-1?

    The NDC Packaged Code 50488-4125-1 is assigned to a package of 20 bar, chewable in 1 bottle of Diphenhydramine Hcl 12.5mg Antihistamine, a human over the counter drug labeled by Alexso, Inc. The product's dosage form is bar, chewable and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package.

    Is NDC 50488-4125 included in the NDC Directory?

    Yes, Diphenhydramine Hcl 12.5mg Antihistamine with product code 50488-4125 is active and included in the NDC Directory. The product was first marketed by Alexso, Inc on February 08, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50488-4125-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 20.

    What is the 11-digit format for NDC 50488-4125-1?

    The 11-digit format is 50488412501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-150488-4125-15-4-250488-4125-01